Director, Software Systems, Process and Delivery

Many structural heart patients experience heart failure with limited treatment options. The Implantable Heart Failure Management (IHFM) team part of the AI Product and Platforms organization at Edwards Lifesciences is focused on addressing these unmet needs through pioneering technology that enables earlier more targeted therapeutic intervention. Our work helps clinicians deliver better care and supports patients in living longer healthier lives.

As Director Software Systems Process & Delivery you will lead the sub-function responsible for how IHFMs regulated software and data products are planned documented orchestrated and delivered. Through managers and senior individual contributors you will own delivery execution release readiness process and traceability systems and design control discipline that keeps products audit-ready and aligned to patient clinician quality and regulatory needs.

Based in Irvine California this role is part of a high-impact medtech innovation hub in Orange County where you will collaborate in person with cross-functional teams to shape patient-focused technology.

Drive delivery execution and predictability:

• Own sprint planning execution and delivery across software and data teams driving clear commitments predictable outcomes and fast issue resolution.

• Manage dependencies sequencing and delivery trade-offs across complex initiatives.

Own release orchestration and readiness:

• Lead release orchestration environment promotion and go-live readiness across the sub-function.

• Set release readiness gates including design freeze verification-complete validation-complete risk assessments and post-release monitoring.

• Partner with Test and DevSecOps teams to incorporate their evidence and security gates into release readiness decisions.

Architect scalable process and traceability systems:

• Establish and continuously improve the end-to-end product development process from intake through release so delivery remains consistent compliant and efficient.

• Own the SSDLC traceability model and engineering tool workflows that enable teams to operate with rigor and clarity.

Own design control and audit readiness:

• Lead design control process discipline across the sub-function supporting alignment with 21 CFR 820.30 IEC 62304 ISO 13485 and ISO 14971.

• Ensure delivery process and documentation artifacts are audit-ready and inspection-ready in partnership with Quality and Regulatory teams.

Lead and grow the team:

• Lead the sub-function or a major portion of it through managers and senior individual contributors.

• Build leadership capability across the team through hiring performance management coaching and talent strategy.

Drive metrics and continuous improvement:

• Define and monitor delivery metrics including predictability lead time and throughput and use insights to improve execution and outcomes.

• Bachelors or Masters degree in a related field or equivalent work experience based on Edwards criteria.

• Experience leading Agile delivery execution across software data or technology teams.

• Experience with regulated product development software delivery platforms or data systems.

• This is an onsite role based in Irvine CA. Relocation assistance is not provided and candidates must reside within a 50-mile radius of Irvine to be considered.

• 12 years of progressive experience leading delivery process or software programs of increasing complexity including experience managing managers.

• Deep expertise in regulated software processes SSDLC traceability and release readiness.

• Working knowledge of design controls including 21 CFR 820.30 IEC 62304 ISO 13485 and ISO 14971.

• Proven ownership of end-to-end software and data delivery across multi-team environments with a track record of predictable Agile execution.

• Experience building scalable delivery and development processes and driving organizational change.

• Familiarity with how test automation CI/CD and DevSecOps practices support release readiness with the ability to partner effectively with those teams.

• Strong partnership with Product Management on prioritization sequencing and trade-off decisions.

• Ability to influence engineering data business and executive stakeholders in a matrixed environment.

• Certified Scrum Professional (CSP) Advanced Certified ScrumMaster (A-CSM) PMI-PMP or similar certification.

• SaMD pre-market submission or FDA Case for Quality experience.

• Data-driven mindset strong communication and leadership skills and attention to detail while maintaining focus on delivery outcomes.

• Ability to lead meetings with internal and external stakeholders including vendors and partners to drive alignment and decisions.

Aligning our overall business objectives with performance we offer competitive salaries performance-based incentives and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.
For California (CA) the base pay range for this position is $159000 to $226000 (highly experienced).
The pay for the successful candidate will depend on various factors (e.g. qualifications education prior experience). Applications will be accepted while this position is posted on our Careers website.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.